Singapore legislation
Regulation 15
of Human Biomedical Research (Tissue Banking) Regulations 2019
Regulation 15
Requirements before tissue is removed, supplied or exported
Subregulation 1
Before any tissue which is individually‑identifiable may be removed from the supervision and control of, or supplied by, a tissue bank to any person for use in research carried out by that person in circumstances other than in paragraph (4), the tissue bank must ensure that —
an institutional review board has approved or exempted from review the proposed research that the tissue would be used for; and (b)there is documentary evidence provided by the recipient (such as but not limited to a letter of undertaking) to the effect that the recipient will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor.
Subregulation 2
Before any non‑identifiable tissue may be removed from the supervision and control of or supplied by a tissue bank to any person for use in research carried out by that person, the tissue bank must ensure that —
either an institutional review board has approved or exempted from review the proposed research that the tissue would be used for or the tissue bank is satisfied that there is scientific merit for the proposed research; and
there is documentary evidence provided by the recipient (such as but not limited to a letter of undertaking) to the effect that the recipient will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor.
Subregulation 3
Paragraph (2) does not apply where the non‑identifiable tissue under a tissue bank’s supervision and control is to be exported or otherwise removed from Singapore to a place outside Singapore for use in research.
Subregulation 4
Before any individually‑identifiable tissue under a tissue bank’s supervision and control is to be exported or otherwise removed from Singapore to a place outside Singapore, the tissue bank must ensure that —
appropriate consent has been obtained from the donor for the export or removal, as the case may be; and
there is documentary evidence provided by the recipient (such as but not limited to a letter of undertaking) to the effect that the recipient will ensure that the intended use of the tissue is in accordance with any conditions or restrictions specified as part of the appropriate consent of the donor.